May 19 2012
CardioKinetix Inc., a medical device company pioneering a catheter-based
treatment for heart failure, today announced two-year clinical results
for the first-of-its-kind catheter-based Parachute™ Ventricular
Partitioning Device, a Percutaneous Ventricular Restoration (PVR)
therapy for patients with ischemic heart failure. Results were presented
today during a Trials, Registries and Late Breaking Science Hot Line
session at the 2012 EuroPCR Conference in Paris by Marco Costa, M.D.,
Ph.D., director of the Interventional Cardiovascular Center and the
Research and Innovation Center at the Harrington Heart and Vascular
Institute, University Hospitals Case Medical Center, Case Western
Reserve University in Cleveland, Ohio.
Clinical data from the two first-in-human studies of the Parachute
system presented today show meaningful and sustained low clinical events
for patients with ischemic heart failure two years following treatment
with the device.
Results from 31 treated U.S and European patients demonstrate a near-full
New York Heart Association (NYHA) class improvement at two years compared to
baseline (2.6 vs. 1.9, p<0.01). In addition, reduction in left ventricular
volume was maintained out to two years (p<0.001). Furthermore, the procedure
stabilized the remodeling process as demonstrated by no statistical change in
post-procedure functional volume over a two-year period (p=0.74). The combined
rate of all-cause death and hospitalization due to worsening heart failure was
16.1 percent at one year and 32.3 percent at two years. The rate of cardiac
death was 6.5 percent at two years. These outcomes compare favorably with
current medical therapy in a similar high-risk patient population.
"Heart failure is such a morbid condition and, in spite of our best
efforts, we have so little to offer to our patients. Today we shared
unprecedented news for cardiologists and heart failure patients. It is
difficult to contain our enthusiasm because the procedure is relatively
simple and the outcomes are surprisingly remarkable for such a high-risk
population," said Dr. Costa. "The sustained and concordant improvements
in symptoms, heart function, and clinical outcomes are compelling, with
a very acceptable safety profile. If these results are confirmed in the
upcoming large randomized trial, the Parachute implant will
revolutionize the treatment of patients with ischemic dilated
cardiomyopathy, reducing debilitating symptoms and allowing patients
with heart failure to live with dignity again."
"We are extremely pleased with the two-year clinical results from the
Parachute implant. This data supports the design of our randomized
pivotal trial, in which we anticipate a potential reduction of death and
hospitalization due to worsening heart failure on the order of 30 to 50
percent for patients treated with the Parachute system compared to
optimal medical therapy," said William T. Abraham, M.D., director of the
Division of Cardiovascular Medicine and professor of internal medicine,
physiology and cell biology at The Ohio State University Medical Center.
"This innovative device has the potential to bring together two
cardiology disciplines - heart failure and interventional cardiology -
to address a significant unmet need in heart failure."
"The presentation of this long-term clinical data is an exciting
milestone for CardioKinetix," said Maria Sainz, president and CEO of
CardioKinetix. "We look forward to gathering additional evidence of the
clinical benefits of the Parachute from our European trials as we
prepare to start our pivotal trial of the device, which we believe holds
the potential to improve the lives of tens of thousands of patients
around the world."
After a heart attack, many patients experience enlargement of the left
ventricle of the heart, causing a decrease in cardiac output that
results in heart failure symptoms such as fatigue and shortness of
breath. The healthy portion of the heart not affected by the heart
attack has to compensate for the loss in output and becomes overloaded
over time. Current treatment options for patients whose heart has
enlarged are limited. The Parachute device offers the first minimally
invasive catheter-based treatment to partition the damaged muscle,
excluding the non-functional heart segment from the healthy, functional
segment to decrease the overall volume of the left ventricle and restore
its geometry and function.